Missing Pharmacologic Class from NDF-RT file

May 24, 2016

We are getting these errors in the P21 report for a study.  The issue is “Pharmacological Class” for Levofloxacin.  We used “Fluoroquinolones” with a code of N0000011190.  However, P21 says it is not found in NDF-RT.

Looking in the configuration file supplied with v 2.1.1 I cannot find this reference in there. But it is present when I download the entire text file. I know that I can replace with an updated txt file but will this same error occur with the FDA Enterprise version when we submit?


Dave Borbas